WEB W5-7-5-MVI-3Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00842429110942), received between Aug 15, 2022 and Sep 10, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Separation” (2 reports).

1 other recall cover devices cleared under the same FDA submission (P170032); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Stenosis

  MAUDE report 50724461 ↗
• MalfunctionJul 18, 2024Retraction Problem; Retraction Problem

  AS REPORTED: DEVICE W5-7-5 WAS TOO LARGE FOR THE ANEURYSM AND COULD NOT BE RESHEATHED INTO THE VIA 90 MICROCATHETER. USED SMALLER DEVICE W5-7-4 INSTEAD. PROCEDURE COMPLETED WITHOUT INCIDENT. THE W5-7-5 WAS REMOVED BY RETRACTING IT PARTIALLY INTO THE VIA 17 MICROCATHETER. THIS MADE IT SMALL ENOUGH TO BE REMOVED. IT WAS PULLED BACK INTO A BENCHMARK GUIDE CATHETER AND REMOVED FROM PATIENT. A VIA 17, 45 DEGREE TIP MICROCATHETER WAS USED WITH THE SMALLER DEVICE W5-7-4. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19774656 ↗
• MalfunctionJun 15, 2023Difficult or Delayed Separation; Difficult or Delayed Separation

  DURING A PROCEDURE FOR A PATIENT ENROLLED IN THE WEB PAS STUDY, TWO DETACHERS WERE USED; HOWEVER, NEITHER CONTROLLER SUCCESSFULLY DETACHED THE WEB DEVICE. THE WEB WAS THEN MANUALLY DETACHED WITH A MICROCATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17140634 ↗
• MalfunctionAug 15, 2022Unintended Movement; Difficult or Delayed Separation; Unintended Movement; Difficult or Delayed Separation

  IT WAS REPORTED THAT DURING AN ANEURYSM TREATMENT PROCEDURE, THERE WAS DETACHMENT DIFFICULTY OF THE WEB DEVICE WITH MULTIPLE DETACHMENT ATTEMPTS. ADVANCEMENT OF THE MICROCATHETER TO THE PROXIMAL MARKER OF THE WEB EVENTUALLY AIDED IN DETACHMENT. HOWEVER, THE MANIPULATION OF THE WEB DELIVERY WIRE AND MICROCATHETER RESULTED IN THE WEB BECOMING INVERTED POST DETACHMENT. OCCLUSION OF ANEURYSM WAS ADEQUATE. THE PATIENT HAD GOOD OUTCOME AND WOKE UP MOVING ALL EXTREMITIES AND TALKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15230647 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P170032. One submission often covers many models, so check the product and lot details in each record.

• Z-0170-2023 · Sep 21, 2022 · Open, Classified
  WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneurysm Embolization System.